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September 20, 2019
On Sept. 13, the Food and Drug Administration (FDA) announced that some medications containing the commonly used histamine-2 (H2) blocker ranitidine, which suppresses acid in the stomach, have been found to be contaminated with N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer).[1] As of press time, the FDA had not requested a recall of these products.
Ranitidine is available over-the-counter (OTC) under the brand...
September 20, 2019
On Sept. 13, the Food and Drug Administration (FDA) announced that some medications containing the commonly used histamine-2 (H2) blocker ranitidine, which suppresses acid in the stomach, have been found to be contaminated with N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer).[1] As of press time, the FDA had not requested a recall of these products.
Ranitidine is available over-the-counter (OTC) under the brand name ZANTAC for prevention and treatment of heartburn due to acid indigestion and by prescription in generic form for treatment and prevention of ulcers in the stomach and intestines, gastroesophageal reflux disease and other conditions.
Acting with more appropriate caution than the FDA, Health Canada on Sept. 17 announced that at its request, companies marketing ranitidine products in Canada have stopped further distribution of these medications “until evidence is provided to demonstrate that they do not contain NDMA above acceptable levels.”[2] Canadian regulators noted that NDMA may be found in ranitidine products, regardless of the manufacturer. On Sept. 18, Novartis, one of several makers of generic ranitidine, announced it was halting worldwide distribution of its ranitidine products as a precaution.[3]
NDMA was one of the same contaminants found in certain medications containing the angiotensin receptor blocker (ARB) valsartan and certain other ARB medications that were recalled over the past year.
STAT reported that the online pharmacy Valisure first alerted the FDA about NDMA contamination of ranitidine in June.[4] Valisure, which tests batches of each medicine it sells for impurities, detected the carcinogen in every ranitidine product it analyzed. The company believes the problem is inherent to ranitidine itself because the drug easily converts into NDMA.
What You Can Do
If you take OTC or prescription ranitidine, talk to your doctor about switching to another drug for suppressing stomach acid, such as an antacid or another H2 blocker (for example, cimetidine [TAGAMET HB] or famotidine [PEPCID]).
Read the FDA’s announcement here.
Read Health Canada’s announcement here.
References
[1] Food and Drug Administration. Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. September 13, 2019. https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine. Accessed September 19, 2019.
[2] Government of Canada. Health Canada requests that companies stop distributing ranitidine drugs in Canada while it assesses NDMA; some products being recalled. September 17, 2019. https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/71029a-eng.php. Accessed September 19, 2019.
[3] Silverman E. Sandoz halts global distribution of heartburn med over carcinogen link while Canada tells other manufacturers to stop. September 18, 2019. https://www.statnews.com/pharmalot/2019/09/18/sandoz-halting-worldwide-distribution-of-heartburn-medicines/. Accessed September 19, 2019.
[4] Silverman E. Pharmacy head who researched Zantac link to carcinogen says FDA has ‘downplayed the problem.’ STAT. September 17, 2019. https://www.statnews.com/pharmalot/2019/09/17/zantac-ranitidine-fda-carcinogen-ndma/. Accessed September 19, 2019.
